Method and device for female urinary incontinence

ABSTRACT

A method and device for use in stress female urinary incontinence. A small, flexible adhesive patch is applied directly to the clitoris of a person suffering from stress female urinary incontinence. The adhesive is of a type sufficient to stimulate the mechanoreceptors located in the clitoris whereby to inhibit discharge from the bladder. The patch is formed of a backing sheet of an impervious material containing adhesive on one side. A release liner prevents the adhesive from drying out.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §120 as acontinuation of U.S. patent application Ser. No. 12/999,114 having a371(c) date of Mar. 23, 2011, which is a national stage application ofPCT App. No. PCT/US10/33349 filed on May 3, 2010, which in turn claimsthe benefit of U.S. Provisional Patent App. No. 61/181,556 filed May 27,2009. All of the foregoing priority applications are hereby incorporatedby reference in their entireties.

FIELD OF THE INVENTION

The invention relates to a method and device for relieving or mitigatingthe problems associated with female urinary incontinence.

BACKGROUND OF THE INVENTION

Female urinary incontinence is a troublesome problem for manyindividuals and can be classified into four major categories. From leastto severe:

-   -   stress incontinence, in which a slight urine loss occur due to        the momentary pressure caused by sneezing, coughing, laughing,        or simply lifting a heavy object;    -   urge incontinence, in which a strong frequent desire to void is        accompanied by involuntary urination within a minute or two of        the urge;    -   overflow incontinence, which occurs when the bladder fills        beyond capacity, creating pressure which exceeds urethral        resistance—no urge to urinate is present, so the bladder just        overflows; and    -   continuous incontinence, which is a conscious or unconscious        urination, which is usually the result of an abnormal passage        caused by surgery, trauma, or neural damage.

A number of devises have been proposed to deal with female urinaryincontinence, represented by, for example, U.S. Pat. No. 5,074,855 toRosenbluth et al., U.S. Pat. No. 6,131,575 to Lenker et al., U.S. Pat.No. 6,461,340, to Lenker et al., U.S. Pat. No. 3,789,828 to Schulte,U.S. Pat. No. 5,509,427 to Simon et al. U.S. Pat. No. 4,892,535 toBjornberg et al., U.S. Pat. No. 6,179,775 to Thompson, U.S. Pat. No.6,836,684 to Rijkhoff, and Statutory Invention Registration (SIR) No.H1602 to Brock, the disclosures of each of which are hereby incorporatedherein by reference.

Rosenbluth et al. and both Lenker et al. patents disclose a resilientpad configured to seal against and occlude the urethral meatus, i.e.,the urethral opening. These devices are described as shaped and sized tofit each individual user's anatomy, implying that the application ofthis device requires careful attention for a comfortable fit. Moreover,the devices are designed for individual custom fitting, calling forpredetermined sizes to be trimmed individually for optimal fit,including the use in some cases of a mold of the relevant portions ofthe vulva taken prior to sizing the pad. A mirror or light is suggestedto facilitate insertion, indicating that the devices are difficult toapply and suggests that the device may be designed for clinical use,attended by a physician or health care professional. Moreover, thesedevices do not appear to be designed for highly active women, e.g.running, jogging, high and low impact aerobics or any exercise where themovement of the lower torso is essential. The devices are rigid aroundthe perimeter contributing to discomfort as used in its intendedposition. In addition, the complex construction and individual customfitting indicates a probable high overall cost to the consumer.

Lenker et al. U.S. Pat. No. 6,131,575 discloses in addition to the rigidfemale incontinence device, a more flexible device but only for maleincontinence, shown in their FIGS. 26 to 30, and which is retained onthe glans of a patient's penis by an adhesive layer formed of apressure-sensitive hydrophilic hydrogel.

The device described in Shulte's patent is a mechanical devicesurgically implanted for prolonged use and features a fluid flow valvewhich can be operated manually, in contrast to the present invention'ssimplicity, ease of use and temporary nature as needed at the discretionof the user. In structure, the Shulte device appears to be a rigidmechanical device with a valve. Simon et al.'s device is designed to beinserted directly inside of the urethra with an “expandable balloon atits proximal end,” again, which is in total contrast to our presentinvention. Bjornberg et al. and Brock describe absorbent pads of thetype that can be used as incontinence pads. Brock further describes acontinuous layer of adhesive for securing the pad to a wearer's skin.The pads of both Bjornberg et al. and Brock are intended to cover largegeneral areas.

Thompson describes a device to enhance clitoral stimulation duringintravaginal intercourse, using a hydrophilic, non-allergenic adhesiveto seat a foraminous, elongated, generally triangular shaped pad in thefemale vestibule to lie beneath the labia minora to support and engagethe ventral aspect of the clitoris when it is engorged with blood duringthe arousal phase of female sexual stimulation.

Rijkhoff et al. describes a device that uses an implanted sensor andmeans for generating electrical pulses to stimulate nerves to inhibitcontraction of the detrusor, the muscle that expels urine from thebladder. It recognizes what has been shown by investigators, thatactivation of afferent nerve fibres, innervating mechanoreceptorslocated in the clitoris, has a strong inhibitory effect on the bladder.

BRIEF SUMMARY OF THE INVENTION

The present invention provides a method and device for use in stressfemale urinary incontinence. Somewhat as in the electrical stimulationof mechanoreceptors located in the clitoris, the present methodphysically stimulates the clitoris to provide a strong inhibitory effecton the bladder, relieving stress urinary incontinence. Notwithstandingthe ability to completely relieve, stress incontinence, the device isremarkably simple. Unlike prior devices, it is not an absorbent pad tocatch urine, it is not a clinical device that requires help ininsertion, it does not have a rigid or semi-rigid component, nor does ithave projections, and is not a complicated electronic impulse generator;moreover, the device can be used in the absence of intravaginalintercourse. It is a small, flexible adhesive patch of a size that canbe comfortably applied directly to the clitoris. The patch is formed ofa backing sheet of an impervious film material containing adhesive onone side. A release liner prevents the adhesive from drying out.

More particularly, a method is provided for treating stress femaleurinary incontinence, comprising applying an adhesive directly to theclitoris of a person suffering from stress female urinary incontinence.The adhesive is of a type sufficient to stimulate the mechanoreceptorslocated in the clitoris whereby to inhibit discharge from the bladder,preferably a hydrophilic, non-allergenic adhesive. The adhesive isprovided by the application of the adhesive layer of the above-describedpatch directly to the clitoris. In a more particularized embodiment, themethod involves identifying persons in need of a device or a method fortreating stress female urinary incontinence.

The present invention provides a simple, low cost solution to a vexingproblem, making it affordable and available. It is designed tocomfortably fit any human female who suffers from urinary incontinenceand includes all the necessary elements that compliment comfort, ease ofuse and confidence. The device is produced with soft, pliable materialsthat allow the user to continue daily routines with no discomforts orembarrassing interruptions. The present invention is also designed topermit the user to apply the device with no assistance, whatsoever, fromanyone.

This device can be produced in various sizes, e.g. small, medium andlarge, to accommodate the over the-counter market. It is well suited forhighly active women, e.g. engaging in running, jogging, high or lowimpact aerobics or any exercise where movement of the lower torso isessential. The product is very portable and can be available inindividually sealed and sterilized packages of multiple units, which caneasily fit into the average sized purse or pouch. The cost, comfort,simplicity, portability and ease of use attributed to this device,surpasses all other products presently available in the consumer'sover-the-counter market.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, reference isnow made to the following descriptions taken in conjunction with theaccompanying drawing, in which:

FIG. 1 is a perspective view of the device, in this embodiment having anoval shape, shown with a portion peeled up to better illustrate itsconstruction;

FIG. 2 is a top plan view of the device of FIG. 1;

FIG. 3 is a top plan view of a device similar to the device of FIG. 1,but having a rectangular shape;

FIG. 4 is a top plan view of a device similar to the device of FIG. 1,but having a triangular shape;

FIG. 5 is a sketch of a vagina illustrating components relevant to theinvention; and

FIG. 6 is a cross-section of the clitoral region of the vagina, showingapplication of the patch of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, a generally oval patch 10 of this inventionis shown formed of a backing sheet 16 coated with a layer of adhesive 14and covered with a release sheet/layer 12. The adhesive layer 14 ispreferably pressure sensitive, hydrophilic and non-allergenic, as knownto the art. The patch is approximately 1½ inches long and 1 1/16 incheswide.

The backing sheet 16 is preferably impervious to body fluids (e.g.,urine and/or menses) and is preferably manufactures from a thin,flexible plastic film, although other flexible liquid imperviousmaterials may also be used, all as known to the art. As used herein, theterm “flexible” refers to materials which are compliant and will readilyconform to the general shape and contours of clitoris region. Thebacking sheet 16 material may as described for the backsheet material ofBrock SIR No. H1602, incorporated herein by reference, and can comprisea woven or nonwoven material, polymeric films such as thermoplasticfilms of polyethylene or polypropylene, or composite materials such as afilm-coated nonwoven material, illustrated by a polyethylene film havinga thickness of from about 0.012 mm (0.5 mil) to about 0.051 mm (2.0mils).

The release layer/sheet 12 keeps the adhesive from drying out and can beformed of an adhesive releasing material, as known by the art, and asalso illustrated in Brock SIR No. H1602. Other non-limiting examples ofthe adhesive releasing material/sheet includes paper, resin film,nonwoven fabric, and nonwoven fabric laminated with resin film, eachhaving been treated with silicon. The release layer is removed beforeapplying the patch 10.

The adhesive layer can comprise of a hydrophilic adhesive compositionwhich may be sticky, viscous gel, or a substantially solid composition.The adhesive layer can also comprise of pressure sensitive adhesives(PSA) made from polymer such as acrylic and methacrylic ester homo- orcopolymers, butyl rubber-based systems, silicones, urethanes, vinylesters and amides, olefin copolymers, butyl rubber-based or syntheticrubbers, and the like. In another embodiment, the adhesive layer cancomprise of bioadhesives (BAs), as known to the art. In contrast to PSAsthat adhere mainly to dry substrates, BAs exhibit good tack when adheredto hydrated biological substrates/tissues. Non-limiting examplesincludes slightly cross-linked polyacrylic and polymethacrylic acids aswell as blends of hydrophilic cellulose derivatives (40-95%) withpolyethylene glycol. In other embodiments, the adhesive layer cancomprise different combinations of PSA and BA polymeric materials ofdifferent hydrophilicity and thus different solubilities in water or inthe liquids secreted by the tissue area in contact with the adhesivelayer.

Regardless of the adhesive composition used, the final adhesive layershould preferably be pressure sensitive, hydrophilic and non-allergenic.

While a single patch 10 is shown in FIG. 1, in actual production and/orsale, a plurality of such patches may be formed on a single releasesheet and sold as a kit whereby individual patches can be removed andapplied as needed.

FIG. 3 shows a patch constructed in the same manner as the patch of FIG.1, but having a generally rectangular shape) 1½ inches long and 1 and1/16 inches wide.

FIG. 4 shows a patch constructed in the same manner as the patch of FIG.1, but having a generally triangular shape 1 and ½ inches high and 1 and¾ inches at its base.

The patch 10 is applied with the adhesive layer directly on theclitoris. FIG. 5 is a sketch of a vagina illustrating relevantcomponents of a vagina, including the vaginal opening 18, the urethralopening 20, the labia minora 22, the labia majora 24, the clitoral hood26 and the clitoris at 28. Referring to FIG. 6, the patch 10 is appliedbetween opposing folds of the labia majora 24 with the adhesive layer 14directly contacting the clitoris 28 and covering the clitoral shaft 30.The adhesive layer 14 is protected from body fluids and, in itsposition, physically stimulates the clitoris 28 to provide a stronginhibitory effect on the bladder, relieving stress urinary incontinence.

Although the present invention has been described in connection with thepreferred embodiments, it is to be understood that modifications andvariations may be utilized without departing from the principles andscope of the invention, as those skilled in the art will readilyunderstand. Accordingly, such modifications may be practiced within thescope of the following claims.

What is claimed is:
 1. A method for treating stress female urinaryincontinence, comprising applying an adhesive to the clitoris of aperson suffering from stress female urinary incontinence.